The Effect of Ganglion Sphenopalatine Block Versus Placebo on Persistent Headache Following COVID-19 Infection
NCT ID: NCT04636034
Last Updated: 2022-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
18 participants
INTERVENTIONAL
2021-01-12
2022-06-06
Brief Summary
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Detailed Description
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Primary outcome is hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the headache in standing position 30 minutes after block in the group Ropicavain-Lidocain and "sham".
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ropivacaine-Lidocaine
Sphenopalatine Ganglion Block with Local Anesthetic
Block performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL
Placebo
Sphenopalatine Ganglion Block with Placebo (Isotone NaCl)
Block performed with bilaterally inserted q-tips with isotone NaCl
"Sham"-block with Placebo
"Sham"-block with Placebo (Isotone NaCl)
Block performed with bilaterally inserted q-tips with isotone NaCl. The q-tips are inserted a maximum of 3 cm into the nasopharynx thus not reaching the mucus above the ganglion.
Interventions
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Sphenopalatine Ganglion Block with Local Anesthetic
Block performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL
Sphenopalatine Ganglion Block with Placebo (Isotone NaCl)
Block performed with bilaterally inserted q-tips with isotone NaCl
"Sham"-block with Placebo (Isotone NaCl)
Block performed with bilaterally inserted q-tips with isotone NaCl. The q-tips are inserted a maximum of 3 cm into the nasopharynx thus not reaching the mucus above the ganglion.
Eligibility Criteria
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Inclusion Criteria
* Moderate to severe headache (NRS \>= 3) with self reported duration of minimum 6 hours during the past week as well as moderate to severe headache (NRS \>= 3) on the day of intervention.
* Onset of headache during or maximum 4 weeks after PCR-verified COVID-19 infection.
* Headache must have persisted for at least 4 weeks following COVID-19 diagnosis.
Exclusion Criteria
* Patients who does not understand or speak Danish
* Allergy to the drugs used in the study
* Has taken opioids within 12 hours prior to intervention
* History of migraine or persistent headache before COVID-19 infection.
* Active COVID-19 infection (defined by the Danish Goverment regulations, i.e. 48 hours after last symptoms (omitting long term effects) or 7 days after positive COVID-19 test if no symptoms.
18 Years
ALL
No
Sponsors
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University Hospital Bispebjerg and Frederiksberg
OTHER
Responsible Party
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Mads Seit Jespersen
MD
Principal Investigators
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Christian S Meyhoff, PhD
Role: STUDY_DIRECTOR
University Hospital Bispebjerg and Frederiksberg
Locations
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Bispebjerg and Frederiksberg Hospital, University of Copenhagen
Copenhagen, , Denmark
Countries
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Other Identifiers
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GSPB-COVID-2020
Identifier Type: -
Identifier Source: org_study_id
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